Cytokeratin 8 Level in Age-related Macular Degeneration

NCT02707575 | Completed

• 1 other identifier: 3-2015-0304
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.

Conditions

Age-related Macular Degeneration

Keywords

Keratin; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity

  The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity

  From baseline to one month after three monthly consecutive ranibizumab injection

Secondary Outcomes (1)

• The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)

  From baseline to one month after three monthly consecutive ranibizumab injection

Study Arms (1)

Ranibizumab

Intravitreal Ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Three monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed.

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Included patient is required to be least 50 years of age with newly diagnosed exudative age-related macular degeneration, with a recent onset of disease.

You may qualify if:

• Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
• A recent onset of disease confirmed by history and clinical findings.
• Patient is required to be least 50 years of age

You may not qualify if:

• Myopia with a refractive error \>-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
• Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
• History of cataract surgery within 3 months prior to presentation
• Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
• Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
• Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location

Sponsors & Collaborators

• Gangnam Severance Hospital: lead
• Konkuk University: collaborator
• Inje University: collaborator
• Novartis: collaborator
• Severance Hospital: collaborator

Study Sites (2)

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Suk Ho Byeon, MD. Ph.D.

  Professor. Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 14, 2016
• Study Start: April 26, 2016
• Primary Completion: March 12, 2018
• Study Completion: April 23, 2018
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)